Patient Safety News: FDA adds new, stronger warning for Essure birth control implant

Essure contraceptive implants originally produced by Conceptus Inc. and now by Bayer Healthcare Pharmaceuticals being required to add a black boxed warning its most serious type to notify potential users of risks associated with the device. A patient decision checklist that doctors will use to make sure patients understand the risks involved is also being proposed.

Essure is a permanent form of birth control that does not require surgery or anesthesia for placement. Two nickel-titanium alloy coils are inserted into both fallopian tubes where they develop a buildup of scar tissue. The buildup prevents sperm from fertilizing the eggs of the patients.

Essure was approved by the United States Food and Drug Administration (FDA) on November 4, 2002. Initial research conducted on the product did not account for the long-term effects of the birth control which include the following:

  • Persistent pain
  • Bleeding
  • Device migration from the fallopian tubes
  • Perforated uterus and/or fallopian tubes
  • Allergic reactions including hives, itching, and rashes

Some of the issues are severe enough to require the device to be surgically removed.

According to a February 2016 FDA press release, Bayer is required to conduct postmarket surveillance of their product. The following is an excerpt from the press release:

“The U.S. Food and Drug Administration announced today actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. The FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women. The FDA also intends to require changes to product labeling, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device.”

From the initial approval in 2002 to December 31, 2015, the FDA received 9,900 medical device reports regarding the product from doctors, patients, and the manufacturers of Essure.

Berman & Simmons attorney Susan Faunce is handling cases involving dangerous drugs and medical devices. “It’s the responsibility of the manufacturers of these devices to put safe products on the market and to express the possible risks related to those products in advance,” said Faunce.